Safety oversight – key responsibilities:

• Trial Steering Committee (TSC): strategic oversight, final decision-making, protocol amendments
• Trial Management Committee (TMC): day-to-day operations, site coordination, quality management
• Data Safety Monitoring Board (DSMB): independent safety monitoring, interim Bayesian analysis review, validate stopping/modification recommendations proposed by SRT
• Safety Review Team (SRT): blinded safety assessment on a regular basis during the study and reporting to the DSMB